Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin Lymphoma

Inclusion Criteria

• •1. Subjects must have histologically confirmed non-Hodgkin lymphoma relapsed after 2 or more lines of therapy or disease refractory to chemotherapy (defined as progressive disease or stable disease lasting ≤6 months, as best response to most recent chemotherapy regimen; or disease progression or recurrence ≤12 months after prior autologous stem cell transplantation (ASCT).
• •2. No evidence of central nervous system (CNS) lymphoma.
• •3. Male or female \> 18 years of age.
• •4. Eastern Cooperative Oncology Group Performance status ≤ 2.
• •5. At least one measurable lesion.
• •6. \>2 weeks since prior radiation therapy or systemic therapy at the time of leukapheresis.
• •7. Total bilirubin ≤ 1.5 mg/dL (except in patients with Gilbert's syndrome).
• •8. Aspartate aminotransferase/alanine transferase ≤ 2.5 X institutional upper limit of normal.
• •9. Serum creatinine \< 1.5 mg/dL.
• •10. Cardiac ejection fraction of \>50%, and no evidence of pericardial effusion, as determined by an echocardiogram.
• •11. Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.
• •12. Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.
• •13. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \< 1% per year during the treatment period and for at least 90 days after the BAFF CAR-T cell infusion.
• •14. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.